Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence : a 3-year follow-up of a randomized controlled trial
Alexandridis, Vasileios LU
; Rudnicki, Martin
; Jakobsson, Ulf
LU
and Teleman, Pia
LU
(2019)
In International Urogynecology Journal
30(9).
p.1465-1473
- Abstract
Introduction and hypothesis: The aim of this study was to compare the long-term subjective outcomes of an adjustable single-incision sling (Ajust®) vs standard mid-urethral slings (SMUS) for the treatment of women with stress urinary incontinence. Methods: This study was designed as a multicenter prospective randomized trial. Women under 60 years old with objectively verified stress urinary incontinence were included from seven centers in three countries. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either Ajust® or SMUS. Women analyzed at 1-year follow-up received the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF),... (More)
Introduction and hypothesis: The aim of this study was to compare the long-term subjective outcomes of an adjustable single-incision sling (Ajust®) vs standard mid-urethral slings (SMUS) for the treatment of women with stress urinary incontinence. Methods: This study was designed as a multicenter prospective randomized trial. Women under 60 years old with objectively verified stress urinary incontinence were included from seven centers in three countries. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either Ajust® or SMUS. Women analyzed at 1-year follow-up received the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF), International Consultation on Incontinence Questionnaire Overactive Bladder, Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Questionnaire-12, Patient Global Impression of Severity, and Patient Global Impression of Improvement questionnaires, together with a bladder diary to fill out at least 3 years after the procedure. The main outcome evaluated was the subjective cure rate as reported through the ICIQ-UI-SF questionnaire at 3 years. Results: In total, 205 women participated in the 3-year follow-up: 107 in the Ajust® and 98 in the SMUS group. No significant difference was observed between the groups regarding subjective cure rate (50.9% vs 51.5%, p = 0.909) or dyspareunia. Both groups demonstrated similar postoperative perception of improvement in addition to reduced urgency and urge urinary incontinence. The postoperative improvement remained at the same level after 3 years as it was at 1-year follow-up for both Ajust® and SMUS. Conclusions: Ajust® appears to be equally effective and safe as SMUS with regard to long-term follow-up of patient-reported outcomes.
(Less)
- author
- Alexandridis, Vasileios
LU
; Rudnicki, Martin
; Jakobsson, Ulf
LU
and Teleman, Pia
LU
- organization
- publishing date
- 2019-09
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Mid-urethral sling, Mini-sling, Single-incision sling, Stress urinary incontinence
- in
- International Urogynecology Journal
- volume
- 30
- issue
- 9
- pages
- 9 pages
- publisher
- Springer
- external identifiers
-
- pmid:31222572
- scopus:85067889830
- ISSN
- 0937-3462
- DOI
- 10.1007/s00192-019-04004-w
- project
- The use of implants in surgical treatment of urinary incontinence and pelvic organ prolapse in women
- language
- English
- LU publication?
- yes
- id
- d2917b6a-0dd0-4f74-8ffc-abf0dc20b129
- date added to LUP
- 2019-07-08 10:29:16
- date last changed
- 2024-06-12 23:58:49
@article{d2917b6a-0dd0-4f74-8ffc-abf0dc20b129,
abstract = {{<p>Introduction and hypothesis: The aim of this study was to compare the long-term subjective outcomes of an adjustable single-incision sling (Ajust®) vs standard mid-urethral slings (SMUS) for the treatment of women with stress urinary incontinence. Methods: This study was designed as a multicenter prospective randomized trial. Women under 60 years old with objectively verified stress urinary incontinence were included from seven centers in three countries. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either Ajust® or SMUS. Women analyzed at 1-year follow-up received the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF), International Consultation on Incontinence Questionnaire Overactive Bladder, Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Questionnaire-12, Patient Global Impression of Severity, and Patient Global Impression of Improvement questionnaires, together with a bladder diary to fill out at least 3 years after the procedure. The main outcome evaluated was the subjective cure rate as reported through the ICIQ-UI-SF questionnaire at 3 years. Results: In total, 205 women participated in the 3-year follow-up: 107 in the Ajust® and 98 in the SMUS group. No significant difference was observed between the groups regarding subjective cure rate (50.9% vs 51.5%, p = 0.909) or dyspareunia. Both groups demonstrated similar postoperative perception of improvement in addition to reduced urgency and urge urinary incontinence. The postoperative improvement remained at the same level after 3 years as it was at 1-year follow-up for both Ajust® and SMUS. Conclusions: Ajust® appears to be equally effective and safe as SMUS with regard to long-term follow-up of patient-reported outcomes.</p>}},
author = {{Alexandridis, Vasileios and Rudnicki, Martin and Jakobsson, Ulf and Teleman, Pia}},
issn = {{0937-3462}},
keywords = {{Mid-urethral sling; Mini-sling; Single-incision sling; Stress urinary incontinence}},
language = {{eng}},
number = {{9}},
pages = {{1465--1473}},
publisher = {{Springer}},
series = {{International Urogynecology Journal}},
title = {{Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence : a 3-year follow-up of a randomized controlled trial}},
url = {{http://dx.doi.org/10.1007/s00192-019-04004-w}},
doi = {{10.1007/s00192-019-04004-w}},
volume = {{30}},
year = {{2019}},
}